Guidelines for Reproductive Medicine in Japan

Mitsutoshi Yamada1 | Tomonori Ishikawa2 | Takeshi Iwasa3 | Hajime Oishi4 | Satoko Osuka5 | Kenji Oka6 | Shuichi Ono7 | Masanori Ono8 | Makoto Orisaka9 | Haruhiko Kanasaki10 | Yasushi Kawano11 | Kazuhiro Kawamura12 | Hiroshi Kishi13 | Fuminori Kimura14 | Shinnosuke Kuroda15 | Akira Kuwahara16 | Hideyuki Kobayashi17 | Akira Komiya18 | Hidekazu Saito19 | Kenji Sato20 | Suguru Sato21 | Koji Shiraishi22 | Hiromitsu Shirasawa23 | Tatsuya Suzuki24 | Yasushi Takai25 | Seido Takae26 | Toshifumi Takahashi27 | Tsuyoshi Takiuchi28 | Masahito Tachibana29 | Isao Tamura22 | Hiroshi Tamura22 | Seung Chik Jwa30 | Tsuyoshi Baba31 | Miyuki Harada32 | Tetsuya Hirata33 | Atsushi Fukui34 | Yusuke Fukuda35 | Shinichiro Fukuhara28 | Tetsuo Maruyama1 | Yasushi Yumura15 | Osamu Yoshino36 | Yasushi Hirota32 | Akira Tsujimura37 | Naoaki Kuji8 | Yutaka Osuga32


| INTRODUC TI ON
Assisted reproductive technology (ART) is a relatively new field compared with other medical treatments; so far, the evidence that forms the basis of medical treatment and treatment guidelines has yet to be sufficiently established. In addition, there has been a tendency in the past for new techniques to be introduced into on-thejob medical care without evidence being established. As we entered the 21st century, evidence gradually increased, and the need for accurate evaluations of medical technologies has increased worldwide, resulting in the creation of multiple guidelines in Western countries in the last 10 years or so.
Based on the "Law concerning special provisions of the Civil Code concerning the provision of assisted reproductive technology and the parent-child relationship of children born as a result" promulgated on December 11, 2020, in Japan, ART has been covered by insurance from April 2022 as a concrete measure (Act No. 76 of 2020). As a reference when considering insurance coverage, the government has requested the Japan Society for Obstetrics and Gynecology, which deals with obstetrics and gynecology in general, and the Japan Society for Reproductive Medicine, which deals with ART, including male infertility, to create medical treatment and treatment guidelines. Within this context, it was decided that medical care and treatment guidelines be created based on the actual medical conditions and evidence in Japan. Since this guideline is written in Japanese, there were some inconveniences for those who are not native speakers of the Japanese language. An English version was created to overcome this problem. This book includes "commentary," "actual conditions," "usage of drugs," "reference list," and "charts," but these parts have been omitted owing to space limitations. Furthermore, the description of the general infertility area has been excluded from this document to avoid duplication with the Obstetrics and Gynecology Practice Guidelines Gynecology Outpatient Edition 2020, which was edited and supervised by the Japan Society of Obstetrics and Gynecology and the Japan Association of Obstetricians and Gynecologists.
As the Japan Society for Reproductive Medicine participated in the editing of these guidelines, we would like to add that we take great responsibility as an organization of medical researchers/medical professionals in helping patients suffering from infertility and hope that we can contribute to the healthy birth and growth of children who will usher our country into the future.
2 | IMPLI C ATI ON S OF "A ," " B ," AND "C " RECOMMENDATION LE VEL S Recommendation levels (strength) "A," "B," and "C" are shown in each CQ and answer. These recommendation levels were created by comprehensively considering the clinical usefulness, evidence, penetrance, and medical economic viewpoint of the recommended testing and treatment methods. Therefore, the answers are not necessarily based on "evidence." When evidence is lacking, a decision is reached by considering the balance between benefit and harm, values and preferences, penetrance, costs, and resource utilization.
The recommendation levels are interpreted as follows: A: Highly recommended (for implementation, etc.), B: Recommended (for implementation, etc.), C: Considered (for implementation, etc.). Factors that determine the recommendation level include the quality of evidence, balance between benefits and harm, values and preferences, penetrance, cost, and resource utilization. The recommendation level is likely to be higher as the overall evidence increases in strength, if the desired effects outweigh the undesired effects and the gap between the two increases, and when the costs resources correspond to the net benefits.

| Terminology
Ovulation induction is defined as pharmacological treatment with the intention of inducing normal ovulatory cycles of women with anovulation or oligo-ovulation for timed intercourse or intrauterine insemination (non-ART). Ovarian stimulation is defined as pharmacological treatment with the intention of inducing the development of ovarian follicles for IVF/ICSI (ART). Chapter G. Add-on medical treatment (CQ029-CQ035).
Chapter I. Male infertility (CQ037-040). • Be a specialist in obstetrics and gynecology certified by the Japan Society of Obstetrics and Gynecology and has been engaged in infertility treatment for more than two years after becoming a specialist.

| CLINI C AL QUE S TI ON S AND AN
• Have worked at a registration facility for in vitro fertilization/embryo transfer (registered facility for ART) of the Japan Society of Obstetrics and Gynecology for one year or more or have received training for one year or more and have learned the techniques of in vitro fertilization/embryo transfer.
• Be full-time physicians.
• Ideally, be reproductive medicine specialists certified by the Japan Society for Reproductive Medicine.
1. Non-physician personnel must meet the following conditions. (A) • One or more nurses.
• One or more technicians (physician or embryo culture specialists) who are able to handle embryos. Ideally, a facility that collects eggs for 150 cycles or more per year should have two or more embryo culture specialists.

ACK N OWLED G M ENT
We would like to thank the editorial committee and academic committee of the Japan Society for Reproductive Medicine for proofreading the manuscript.